The BREATHER Plus study is evaluating whether simpler treatments maintain control of HIV but are easier for adolescents to manage.

Improving the quality of life of adolescents living with HIV

Adolescents who acquire HIV or were infected at birth are currently obliged to take antiretroviral drugs every day for the rest of their lives. This daily routine can be challenging for young people to stick to.

International trials have identified alternative approaches that simplify treatment schedules. These include a ‘weekends off’ approach, in which young people take a two-day break from treatment, and monthly use of a long-acting injectable antiretroviral.

The challenge

The BREATHER Plus trial will compare these two new approaches – weekends off and a monthly injectable – with standard treatment in adolescents in four African countries. The oral regimens will be based on dolutegravir, an increasingly used antiretroviral. Importantly, the trial will take place in settings where viral load is monitored annually, as recommended by WHO, so any resurgence of HIV can be detected.

The trial will last 96 weeks and will assess control of HIV replication, the side effects of treatment, impacts on quality of life, and acceptability of the new approaches.

The project

The BREATHER Plus trial will generate evidence that could influence the treatment, and improve the quality of life, of more than 2 million adolescents living with HIV – most of whom are in sub-Saharan Africa.

Impact


crucial in

widening African

children’s access

to antiretrovirals

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Adolescents who acquire HIV or were infected at birth are currently obliged to take antiretroviral drugs every day for the rest of their lives. This daily routine can be challenging for young people to stick to.

International trials have identified alternative approaches that simplify treatment schedules. These include a ‘weekends off’ approach, in which young people take a two-day break from treatment, and monthly use of a long-acting injectable antiretroviral.

The BREATHER Plus trial will compare these two new approaches – weekends off and a monthly injectable – with standard treatment in adolescents in four African countries. The oral regimens will be based on dolutegravir, an increasingly used antiretroviral. Importantly, the trial will take place in settings where viral load is monitored annually, as recommended by WHO, so any resurgence of HIV can be detected.

The trial will last 96 weeks and will assess control of HIV replication, the side effects of treatment, impacts on quality of life, and acceptability of the new approaches.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The BREATHER Plus trial will generate evidence that could influence the treatment, and improve the quality of life, of more than 2 million adolescents living with HIV – most of whom are in sub-Saharan Africa.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

Projects: CAPRISA 018 study

Project lead: Professor Salim Abdool Karim, Centre for the AIDS Programme of Research in South Africa, South Africa

Countries involvedFrance, The Netherlands, South Africa

Target population(s): Women

Year funded: 2017

EDCTP funding: €9.8 M

Total project funding: €11.4M plus donation of study drugs

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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